Comprehensive Regulatory Medical Writing Services
BioPoint has found that successful regulatory programs rely heavily on an experienced and knowledgeable medical writing team. From package inserts, patient information leaflets and clinical study reports to a wide variety of regulatory submission documents, a regulatory medical writer must have a deep, versatile understand of the industry and its ever-evolving intricacies.
Our regulatory medical writing consultants can function as a virtual department on an as-needed basis, or augment an existing medical writing team.
Our consultants bring experience in writing:
- Phase I-IV protocols
- Phase I-IV integrated clinical statistical reports (ICSR)
- Standard Operating Procedure (SOP) writing
- Global clinical trial applications
- Drug, device and biologics marketing applications
- Preclinical and scientific reports
- Investigator brochures
- Premarketing and post-approval annual reports
- Patient safety narratives
- FDA briefing documents
- Risk management plans
- Pediatric investigatory plans
With the heavy regulations in today’s medical industries, and the increasing number of research studies and the continued development of new drugs and medical devices, having experience and versatile medical writers at your disposal is vital to your company’s success. When determining the course of your regulatory program, be sure to have medical writers available to help create the strong and cohesive voice that your products and company need.
Learn More About Regulatory Medical Writing From BioPoint
For more information on how we can provide successful regulatory medical writing solutions to your company, please contact us at 781-218-3790 or firstname.lastname@example.org. We look forward to providing the accurate and thorough medical writing that your company needs.